Phenylephrine and Hypotension During Spinal Anesthesia for Cesarean Section

Assiut University

Status and phase: Completed; Phase 2

Conditions: Anesthesia, Spinal; Anesthesia, Obstetrical

Treatments: Other: Placebo; Drug: Phenylephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02958215

IRB0000871230

Details and patient eligibility

About

Pregnant women with a positive preoperative Supine stress test were found to be a subgroup at increased risk of symptomatic hypotension after spinal anesthesia

Full description

Patients will be placed in dorsal decubitus dislocating the uterus to the left for a few minutes, with blood pressure and heart rate recorded three times, with a three-minute interval between measurements to obtain mean baseline levels and this will be repeated in an upright position to record the same measurement.Orthostatic hypotension (Orthostatic hypotension "OH" is defined specifically as a 20mmHg drop in systolic, and/or a 10mmHg drop in diastolic blood pressure within 3 minutes of standing.

Enrollment: 980 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Physical status ASA I, A full term pregnancy A single fetus Elective cesarean section.

Exclusion criteria

Refusal of the patient to participate in the study History of hypertension Pregnancy-induced hypertension Cardiovascular or cerebrovascular disease Fetal abnormalities History of hypersensitivity to the drugs used Contraindications to spinal block.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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980 participants in 2 patient groups, including a placebo group

Group A

Placebo Comparator group

Description:

This group will include patients with orthostatic hypotension and will be managed with routine spinal anesthesia Ephedrine will be used for management of intraoperative hypotension

Treatment:

Other: Placebo

Group B

Active Comparator group

Description:

This group will include patients with orthostatic hypotension and will be managed with prophylaxis single dose of phenylephrine, 50 ug IV, will be administered immediately before the spinal block then the patients will be managed with routine spinal anesthesia Ephedrine will be used for management of intraoperative hypotension

Treatment:

Drug: Phenylephrine